An interventional study of Napoleon and Visual estimation in Gastric Bypass and Weight Regain, sponsored by NYU Langone Health. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Device feasibility
This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. History of prior endoscopies with complications
The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital.
Device: Napoleon · Other: Visual estimation
The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational.
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation
Time frame: 8 months
Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device
Time frame: 8 months
Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition
Time frame: 8 months
Additional procedure time needed to incorporate use of Napoleon
Time frame: 8 months
Proportion of cases with adverse events or unanticipated problems related to use of Napoleon
Time frame: 8 months
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Violeta.Popov@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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